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Samsung Enters Oncology as Trastuzumab Accepted For EU Review

 
• By Jung Won Shin

Samsung Bioepis's trastuzumab has become the South Korean company’s fifth biosimilar candidate to be filed for approval in Europe and also marks its planned entry into the oncology sector in the region.

The European Medicines Agency (EMA) has accepted for review Samsung Bioepis Co. Ltd.’s marketing authorization application (MAA) for SB3, a biosimilar version of Roche’s Herceptin (trastuzumab), following a regulatory submission made in August.

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